How do you go about conducting research to develop a new behavioral treatment for drug abuse and proving it can work in a community clinic? It's not easy, says Dr. Lisa Onken of NIDA's Division of Clinical and Services Research. In fact, few people have done it because there has been little Federal support for such research and no established systematic method for conducting behavioral studies, Dr. Onken says. That's why she called the first researchers in NIDA's behavioral therapies development program "pioneers" when they met earlier this year with NIDA program staff members. Researchers from a similar National Institute of Mental Health program were also invited, and one participated in the meeting.
NIDA held the meeting to work out what elements should go into studies to develop and test behavioral therapies. These studies make up the first stage of the rigorous three-stage process researchers will use to take new behavioral therapies from concept to the clinic. This three-stage process consists of the following:
Stage One Studies
- Researchers will generate and formulate new behavioral therapies based on promising clinical and behavioral science research findings.
- Researchers will write a manual for administering the therapy, train therapists to administer the therapy, and test and refine the therapy based on small-scale studies with patients that culminate in pilot studies.
Stage Two Studies
- Researchers will conduct clinical trials to test promising therapies for efficacy.
- Researchers will further refine their therapies, manuals, and training materials.
- Researchers may also analyze the efficacy of individual components of a therapy and replicate clinical studies conducted by other investigators in different settings.
Stage Three Studies
- Researchers will take therapies that have been effective in controlled clinical trials and, using the manuals and training materials they have developed, determine whether or not the therapies work in community-based treatment settings.
At the work group meeting on stage one studies, NIDA's pioneering behavioral therapies researchers decided that by the end of stage one, researchers should have produced a manual detailing their therapy, a good definition of the target population for the therapy, a training procedure for therapists who will administer the therapy, and a procedure to assess the competence of therapists. Scientists should also have come up with a therapeutic intervention that permits flexibility in treatment, measures of client change and outcome, and pilot data showing whether the therapy works or not in producing the desired results in a specified patient group.
In the final analysis, what should result from a stage one study is enough information to determine whether the therapy is ineffective or shows enough promise to move on to stage two testing, says Dr. Onken. NIDA plans to disseminate a report summarizing the behavioral therapies meeting to researchers who are interested in conducting behavioral therapy development studies, Dr. Onken says.